FDA approves a new injection to protect against HIV infection for six months
June 30, 2025
Summary: A new injection provides six months of protection from HIV for those at high risk, but is very expensive.
Sources: Good Rx (first three bars), manufacturer website (Apretude), WSJ (Yeztugo)
The Food and Drug Administration (FDA) last week approved Yeztugo (lenacapavir). an injection that can be used for Pre-exposure Prophylaxis (PrEP) to prevent those at high risk from being infected with human immunodeficiency virus (HIV), which causes Acquired Immunodeficiency Disease (AIDS). I wrote about the research showing this drug’s remarkable effectiveness last summer.
PrEP is currently recommended for men who have sex with men, sex workers, people who are customers of sex workers, transgender women, and those who use intravenous drugs and others at high risk of HIV. PrEP is currently underutilized; under one-quarter of gay men who are eligible take PrEP, which has until now been available as daily pills or an every other month injection. An injection which could be given just twice a year could increase the number of people who would be willing to take this preventive medication and would go far to eliminating the problem of non-adherence.
There is a big ‘but,’ though.
Gilead, the manufacturer, has set a list price of about $28,000 annually. That’s consistent with the list price of Apretude, the other injectable drug given every other month. Since the US Preventive Services Task Force recommends PrEP, employers are currently required to cover all previously approved methods of PrEP without cost sharing, so the majority of plan members are taking expensive brand name medications. The effectiveness of less frequent injections at preventing HIV infections is higher than the effectiveness of once-a-day medications, and the older drug (Truvada and its generic) cause more kidney adverse effects than the other available medications.
Implications for employers:
This new medication is a powerful tool to decrease transmission of HIV, but it is exceptionally expensive.
If this drug is recommended by the US Preventive Services Task Force, employer-sponsored health insurance plans will be required to cover this without cost sharing.
Offering high value drugs with no cost sharing is a central tenet of value based insurance design. However, this allows no plan design to encourage the use of less expensive medications in cases where these would be appropriate.
The PrEP brand name drugs often have substantial rebates, so net cost to employer sponsored plans is lower than the chart above would suggest.